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    10. Roadmap of the Submission Process of a Clinical Trial
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    10. Roadmap of the Submission Process of a Clinical Trial

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    10.1 Clinical Trial with Investigational Medicinal Product

    1. Submit an application to the local ethics committee.
    2. Once approval has been gained, submit a clinical trial application to ANMAT.
    3. Upon payment of the fees, the review period commences.

    10.2 Pediatric Investigation Plan (PIP)

    There is no requirement for a PIP in Argentina.

    10.3 Clinical Study (Interventional or Observational)

    Only interventional trials are regulated by ANMAT. There is no requirement to gain approval for an observational trial.

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